Arcutis Biotherapeutics

Arcutis Biotherapeutics, Inc. engages in the development and commercialization of treatments for dermatological diseases. Its pipeline consists of topical treatments for plaque psoriasis, atopic dermatitis, hand eczema, vitiligo, scalp psoriasis, alopecia areata, and seborrheic dermatitis. The company was founded by Bhaskar Chaudhuri and David W. Osborne in June 2016 and is headquartered in Westlake Village, CA.

Earnings data Q2 2023

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WESTLAKE VILLAGE, Calif., May 24, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced a leadership change. Ken Lock, who has served as Senior Vice President and Chief Commercial Officer (CCO) since October 2019, is stepping down to attend to personal matters effective June 2, 2023. During this transition period, Arcutis' Vice President of Market Access, Ayisha Jeter, has been appointed interim CCO.

Arcutis Announces Leadership Transition

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Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT ) Q1 2023 Results Conference Call May 9, 2023 4:30 PM ET Company Participants Eric McIntyre - Head of Investor Relations Frank Watanabe - President & Chief Executive Officer Patrick Burnett - Chief Medical Officer Ken Lock - Chief Commercial Officer Scott Burrows - Chief Financial Officer Conference Call Participants Vikram Purohit - Morgan Stanley Seamus Fernandez - Guggenheim Securities Uy Ear - Mizuho Louise Chen - Cantor Greg Fraser - Truist Securities Sean Kim - Jones Trading Rohit Bhasin - Needham & Company Operator Good day, and thank you for standing by. Welcome to Arcutis Biotherapeutics Q1 2023 Earnings Conference Call.

Arcutis Biotherapeutics, Inc. (ARQT) Q1 2023 Earnings Call Transcript

Arcutis Biotherapeutics, Inc. (ARQT) came out with a quarterly loss of $1.31 per share versus the Zacks Consensus Estimate of a loss of $1.30. This compares to loss of $1.27 per share a year ago.

Arcutis Biotherapeutics, Inc. (ARQT) Reports Q1 Loss, Lags Revenue Estimates

WESTLAKE VILLAGE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended March 31, 2023, and provided a business update.

Arcutis Announces First Quarter 2023 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., May 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 84,000 restricted stock units of Arcutis' common stock as well as options to purchase an aggregate of 15,000 shares of Arcutis' common stock to nine newly hired employees. These awards were approved by the Compensation Committee of Arcutis' Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of May 1, 2023, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

WESTLAKE VILLAGE, Calif., May 02, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immune-dermatology, today announced the enrollment of the last subject in the INTEGUMENT-PED Pivotal Phase 3 trial evaluating roflumilast cream 0.05% for the treatment of mild to moderate AD in children ages 2 to 5. Roflumilast cream is a once-daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), which the Company is evaluating in two doses for AD: 0.15% for adults and children 6 years of age and older, and 0.05% for children aged 2 to 5 years. Arcutis previously reported positive topline data in similarly designed Pivotal Phase 3 trials of roflumilast cream 0.15% in ages 6 and above.

Arcutis Completes Enrollment in INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5

WESTLAKE VILLAGE, Calif., April 28, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced today that its next-generation topical PDE4 inhibitor therapy for plaque psoriasis, ZORYVE™ (roflumilast) cream 0.3%, has received regulatory approval from Health Canada.

Arcutis Announces Canadian Approval of ZORYVE™ (roflumilast) Cream 0.3% for Treatment of Plaque Psoriasis in Individuals 12 Years and Older

WESTLAKE VILLAGE, Calif., April 25, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a conference call and webcast at 4:30 p.m. ET on Tuesday, May 9, 2023, to report its first quarter financial results.

Arcutis to Report First Quarter Financial Results

Arcutis Biotherapeutics: PDUFA Date Before End Of 2023 Makes This Worth A Look.

Arcutis Biotherapeutics: PDUFA Date Before End Of 2023 Makes This Worth A Look

WESTLAKE VILLAGE, Calif., April 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2023.

Arcutis Announces FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older

WESTLAKE VILLAGE, Calif., April 12, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis management will participate in an upcoming investor conference.

Arcutis to Present at Upcoming Investor Conference

WESTLAKE VILLAGE, Calif., April 05, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous psoriasis, in adults and adolescents is being covered without prior authorizations by an additional eight national and regional health plans effective April 1. Combined with the previously announced coverage from two of the three largest national pharmacy benefit managers and several large national health plans, commercial coverage for ZORYVE for plaque psoriasis now exceeds 110 million commercially covered lives in the United States.

Arcutis Announces New Coverage for ZORYVE® (Roflumilast) Cream 0.3% with National and Regional Health Plan Formularies, Bringing Total Commercial Covered Lives to Over 110 Million

WESTLAKE VILLAGE, Calif., March 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (New Orleans, LA, March 17-21) new data from its INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase 3 studies of roflumilast cream 0.15% in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting

WESTLAKE VILLAGE, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced six presentations at the 2023 American Academy of Dermatology (AAD) annual meeting, which will take place in New Orleans from March 17-21, 2023 and an additional poster at the SOCS Symposium on March 16, 2023. Among these will be the presentation of late-breaking clinical data on roflumilast cream 0.15% in patients aged 6 years and older with atopic dermatitis from the pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 Phase 3 trials.

Arcutis to Present New Topical Roflumilast Data Including Late Breaking Atopic Dermatitis Pivotal Trial Data During the American Academy of Dermatology (AAD) Annual Meeting

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT ) Q4 2022 Earnings Conference Call February 28, 2023 4:30 PM ET Company Participants Eric McIntyre - Head of Investor Relations Frank Watanabe - President & Chief Executive Officer Patrick Burnett - Chief Medical Officer Ken Lock - Chief Commercial Officer Scott Burrows - Chief Financial Officer Conference Call Participants Vikram Purohit - Morgan Stanley Seamus Fernandez - Guggenheim Ken Cacciatore - Cowen Greg Fraser - Truist Louise Chen - Cantor Rohit Bhasin - Needham & Company Uy Ear - Mizuho Group Operator Ladies and gentlemen, thank you for standing by. And welcome to Arcutis Biotherapeutics, Inc. Fourth Quarter 2022 Earnings Conference Call.

Arcutis Biotherapeutics, Inc. (ARQT) Q4 2022 Earnings Call Transcript

WESTLAKE VILLAGE, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter and year ended December 31, 2022, and provided a business update.

Arcutis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

WESTLAKE VILLAGE, Calif., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast foam 0.3% for the treatment of moderate to severe seborrheic dermatitis in adults and adolescents. Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, face, and trunk.

Arcutis Submits Topical Roflumilast Foam 0.3% New Drug Application to the FDA for the Treatment of Seborrheic Dermatitis in Adults and Adolescents

The market has discounted momentum around Arcutis' Zoryve label. This looks overdone and investors appear to have overlooked the additional data points surrounding the segment.

Arcutis Biotherapeutics: Market Discounting Zoryve Momentum

WESTLAKE VILLAGE, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced that it will host a conference call and webcast at 4:30 p.m. ET on Tuesday, February 28, 2022 to report its fourth quarter and full year financial results, and provide a business update.

Arcutis to Report Fourth Quarter 2022 Financial Results and Participate in Upcoming Investor Conference

WESTLAKE VILLAGE, Calif., Jan. 14, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced new safety and efficacy durability data from its open label Phase 2 long-term safety study evaluating once-daily roflumilast cream (0.3%) in adults with chronic plaque psoriasis. Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022.

Arcutis Presents New Phase 2 Long-Term Data Showing Sustained Efficacy and Clearance for a Median of 10 Months with Roflumilast Cream in Adults with Chronic Plaque Psoriasis

WESTLAKE VILLAGE, Calif., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the expanded indication of ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 11. As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features.

Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% for Expanded Indication for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age

WESTLAKE VILLAGE, Calif., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from its INTEGUMENT-2 pivotal Phase 3 trial of roflumilast cream 0.15%, a once-daily, non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). The study met its primary endpoint, with 28.9% of individuals treated with roflumilast cream 0.15% achieving IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear' or ‘almost clear' plus a 2-grade improvement from baseline at Week 4, compared to 12.0% of individuals treated with vehicle (P

Arcutis Announces Positive Topline Results from Second Atopic Dermatitis Pivotal Phase 3 Trial of Roflumilast Cream in Adults and Children Aged 6 and Older

WESTLAKE VILLAGE, Calif., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the first subject has been enrolled in a Phase 1b study evaluating ARQ-255, a topical suspension of ivarmactinib, a potent and specific janus kinase 1 (JAK1) inhibitor, for the treatment of alopecia areata. ARQ-255 has been specifically formulated with Arcutis' proprietary 4D technology to deliver drug deep into the skin to the base of the hair follicle, the site of the inflammation that underlies alopecia areata.

Arcutis Enrolls First Patient in Phase 1b Alopecia Areata Study Evaluating ARQ-255

MySebDermTeam provides trusted connection, information, and support to accelerate diagnosis and treatment SAN FRANCISCO, Dec. 1, 2022 /PRNewswire/ -- MyHealthTeam , creator of the largest and fastest-growing social networks for people living with chronic health conditions, today launched MySebDermTeam , an online community for those living with seborrheic dermatitis to find the people, support, and medically-reviewed information they need to better manage their condition. Created by MyHealthTeam, with sponsorship by Arcutis Biotherapeutics, an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, MySebDermTeam empowers individuals with information that helps them more effectively work with doctors throughout their seborrheic dermatitis diagnosis and treatment journey.

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